| - | - | - |
|---|---|---|
| Product Group | : | Parasiticides |
| Pharmaceutical Form | : | Solution for Injection |
| Active Ingredient | : | Buparvaquone |
| Target Species | : | Cattle |
| Package Form | : | 50 ml |
For Veterinary Use Only
For Veterinary Use Only
Solution for Injection
Veterinary Antiprotozooner
COMPOSITION
Buparcel Solution for Injection is a clear, red-dark brown colored sterile solution containing 50 mg Buparvaquone and 500 mg N-methyl-2-pyyrolidone per ml.
PHARMACOLOGICAL PROPERTIES
Buparvaquone is antiprotozooner belong to second generation of hydroxynaphthoquinone group.
Buparcel Solution for Injection; The tertiary-butyl bond in its composition provides a long plasma half-life and the cyclohexyl ring in the 4-position allows it to be metabolized slowly. Buparvaquon is effective on schizont and proplasm in cattle. Its effectiveness is parasite-specific. It does not develop adverse effects on host lymphocytes. When Buparvacuone is administered intramuscularly at a dose of 2.5 mg/kg, the maximum plasma concentration is 1.102 μg/kg, the time to peak plasma concentration is 3.27 hours, the excretion half-life is 26.44 hours and the volume of distribution is 35.381/kg. It is generally excreted with gaita after entero-hepatic circulation.
AREA OF USE / INDICATIONS
It is used for the treatment of all form of Theileriosis caused by Theilleria annulata, T. parya, T. mutans and T. sergenti in cattle.
USAGE AND DOSAGE
It is only administered intramuscularly through deep cervical muscle in cattle.
Pharmacological dose: 2,5 mg/kg body weight.
Practical dose: 1 ml for 20 kg body weight. In case a dose volume extends over 10 ml, it is injected through two different area after being separated into two volumes.
A single dose is sufficient for treatment generally. Considering serious cases, a second dose administration may be needed after 48-72 hours.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
In severe cases of theileriosis, the disease may worsen despite treatment. In this case, treatment should be repeated. It is useful to support the treatment with antibacterial application to prevent secondary infections. The possibility of the disease being confused with other tick-borne diseases and the possibility of co-morbidity should be taken into consideration. It should be remembered that other diseases masked by the symptoms of theileriosis may appear as the animal's immune system weakens. In the presence of Babesiosis and Anaplasmosis in combination with Theileriosis, specific treatment should be given for these diseases. Recovered animals develop specific immunity to the strain that caused the disease. However, a new infection by an antigenically different strain may occur. In this case, treatment with Buparvaquone should be repeated. During the convalescence period, it is important to feed the animal well. Severely infected animals should not be exposed to stress factors such as prolonged walking, transportation, acaricide baths, etc. The presence of anemia is characteristic of theileriosis infections. Anemia should be taken into consideration in treatment. Animals that die from the disease should be sprayed with a suitable acaricide and ticks that may transmit the disease should be killed. Care should be taken to ensure that the injection site is dry and clean. No more than 10 ml should be given to an injection site. In severe cases, if the application is repeated, the injection should be made on the opposite side of the neck where the first application was made.
ADVERSE EFFECTS
Temporary swelling and muscle spasms may be observed in the administration area after the injection.
DRUG INTERACTIONS
Theilleriosis suppresses the immune system and increases susceptibility to secondary bacterial infections. In this case, antibacterial medication should be administered. It is required to wait for the post treatment recovery for bacterial and viral vaccine applications.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
No specific symptoms of overdose have been reported.
WITHDRAWAL PERIODS
Meat: 42 days. Not for use in dairy cattle whose milk is offered for human consumption.
CONTRAINDICATIONS
It should only be used in the treatment of Theileriosis. Not indicated in diseases of other blood parasites (Babesiosis and Anaplasmosis). It is not administered intravenously or subcutaneously.
Use during pregnancy: The safety of this product in cattle during pregnancy, lactation or for breeding purposes has not been established. Laboratory studies in rabbits and rats with the excipient N-methylpyrrolidone have shown evidence of foetotoxic effects. It should only be used according to the benefit-risk assessment by a responsible veterinary surgeon.
GENERAL WARNINGS
Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children and foodstuff. Do not use products with expired shelf life and damaged packaging.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Laboratory studies conducted in rabbits and rats with the excipient N-Methyl Pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women, or women who may become pregnant should take the utmost care to avoid accidental self-injection and contact with the product and should take all necessary precautions.
STORAGE CONDITIONS AND SHELF LIFE
Store below 25 ˚C, in the original package, protect from light. Shelf life is 2 years.
COMMERCIAL PRESENTATION FORM
Offered for sale in 50 ml amber Type II glass vials with 20 mm grey bromobutyl rubber stoppers and 20 mm printed colorless caps with cardboard box.
PLACE AND CONDITIONS OF SALE
Sold with Veterinary Surgeon’s prescription in pharmacies and veterinary surgeries.(VSP)
APPROVAL DATE OF PACKAGE INSERT: 07.08.2025
MARKETING AUTHORIZATION DATE AND NO: 22.03.2010/022-0058
MARKETING AUTHORIZATION HOLDER
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
MANUFACTURER COMPANY
1- Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
2- FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.
Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye
